Communication station and software for interfacing with an infusion pump, analyte monitor, analyte meter, or the like

ABSTRACT

A communication station is for use with a medical device (such as an infusion pump) and a processing device (such as a computer). The communication station includes a housing, a medical device interface coupled to the housing, a processing device interface coupled to the housing and a processor coupled to the housing. The device interface interfaces with the medical device, and the processing device interface interfaces with the processing device. The processor provides a communication path between the medical device and the processing device such that programming and instructions may be communicated from the processing device to the medical device and data may be transferred from the medical device to the processing device. The communication station may be combined with a system that is capable of generating reports either locally or remotely. In addition, the medical device interface may be a cradle that is configurable to attach to different shaped medical devices.

RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 12/140,157filed on Jun. 16, 2008, which is a continuation application of U.S.patent application Ser. No. 10/180,732 filed on Jun. 26, 2002, now U.S.Pat. No. 7,647,237 issued Jan. 12, 2010, which is a divisionalapplication of U.S. patent application Ser. No. 09/409,014 filed on Sep.29, 1999 now abandoned, which claims the benefit of U.S. patentapplication Ser. No. 60/102,469 filed on Sep. 28, 1998, U.S. patentapplication Ser. No. 60/121,565 filed Feb. 25, 1999, U.S. PatentApplication Ser. No. 60/134,981 filed May 20, 1999, and which is acontinuation-in-part of U.S. patent application Ser. No. 29/087,251filed Apr. 29, 1998, now U.S. Pat. No. D434,142 issued Nov. 21, 2000,all of which are specifically incorporated by reference herein.

FIELD OF THE INVENTION

This invention relates to communication stations for medical devicesand, in particular embodiments, to a communication station for use withinfusion pumps, analyte monitors/meters such as glucose monitors,glucose meters, or the like.

BACKGROUND OF THE INVENTION

Traditionally, many modern programmable infusion pumps include internalmemory for generating and storing data representing actual pumpoperation over a period of time. The stored data may be reviewed on aperiodic basis by medical personnel, so that the patient's condition andtreatment regimen can be closely monitored, and the pump reprogrammed asneeded. Unfortunately, data retrieval from the infusion pump and/orphysician-dictated modification of the basic infusion pump program haverequired regular patient visits to a medical treatment facility.

To overcome this drawback, raw data has been transferred from aninfusion pump to another data storage and/or processing device. Anexample of a data transfer system for an infusion pump is disclosed inU.S. Pat. No. 5,376,070 issued Dec. 27, 1994 to Purvis et al. and isentitled “Data Transfer System for an Infusion Pump,” which is hereinincorporated by reference. This device relates to a relatively simpleand effective data transfer system that is designed for retrieving datafrom, and sending program data to, a medication infusion pump. The datatransfer system is particularly suited for remote data transfer and/orreprogramming of the infusion pump.

Over the years, bodily characteristics have been determined by obtaininga sample of bodily fluid. For example, diabetics often test for bloodglucose levels. Traditional blood glucose determinations have utilized apainful finger prick using a lancet to withdraw a small blood sample. Inaddition, all of these systems are designed to provide data at discretepoints and do not provide continuous data to show the variations in thecharacteristic between testing times. The data representing the resultsof the test are often stored in a memory of a glucose meter. The data isthen downloaded into a computer for later review. However, none of thesesystems coordinate infusion pump data with the glucose meter data. Also,these systems generally only download raw data and do not provide foranalysis and presentation of the data in a useful format.

SUMMARY OF THE DISCLOSURE

It is an object of an embodiment of the present invention to provide animproved communication station for medical devices, which obviates forpractical purposes, the above mentioned limitations.

According to an embodiment of the invention, a communication station isfor use with a medical device and a processing device. The communicationstation includes a housing, a medical device interface coupled to thehousing, a processing device interface coupled to the housing and aprocessor coupled to the housing. The medical device interfaceinterfaces with the medical device, and the processing device interfaceinterfaces with the processing device. The processor provides acommunication path between the medical device and the processing devicesuch that programming and instructions may be communicated from theprocessing device to the medical device and data may be transferred fromthe medical device to the processing device. In preferred embodiments,the medical device is an infusion pump, analyte monitor, continuousglucose monitor, glucose meter, or the like, and the processing deviceis a computer. Also, in some embodiments, the medical device interfaceis a cradle that is configurable to attach to different shaped diabetesrelated medical devices.

According to an embodiment of the invention, a communication systemincludes at least one diabetes related medical device, a processingdevice, and a communication station. The communication station includesa housing, a medical device interface, a processing device interface anda processor. The medical device interface is coupled to the housing andinterfaces with the at least one diabetes related medical device. Theprocessing device interface is coupled to the housing and interfaceswith the processing device. The processor is coupled to the housing, themedical device interface and the processing device interface to providea communication path between the at least one diabetes related medicaldevice and the processing device so that programming and instructionsmay be communicated from the processing device to the at least onediabetes related medical device and data may be transferred from the atleast one diabetes medical device to the processing device. In preferredembodiments, the at least one diabetes related medical device is aninfusion pump, analyte monitor, continuous glucose monitor, glucosemeter, or the like, and the processing device is a computer. Also, insome embodiments, the medical device interface is a cradle that isconfigurable to attach to different shaped diabetes related medicaldevices.

In particular embodiments, the processing device uses the datatransferred from the at least one diabetes related medical device togenerate at least one report based on the transferred data. The at leastone report includes infusion pump history and settings, glucose meterhistory and settings, or both. In further embodiments, the at least onereport further includes glucose meter with infusion pump history andglucose monitor history. The at least one report can include tabular andgraphical data, as well as statistical analysis, exception reporting,and clinical recommendations based on expert system analysis.

In other embodiments, the processing device interface includes acommunication circuit for communicating with the processing device, andthe processing device is a remotely located computer. In someembodiments, the remotely controlled computer runs software for anetwork data management service that utilizes the data transferred fromthe at least one diabetes related medical device.

Other features and advantages of the invention will become apparent fromthe following detailed description, taken in conjunction with theaccompanying drawings which illustrate, by way of example, variousfeatures of embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of embodiments of the invention will be made withreference to the accompanying drawings, wherein like numerals designatecorresponding parts in the several figures.

FIG. 1 is a front perspective view of a communication station inaccordance with an embodiment of the present invention.

FIG. 2 is a rear perspective view of the communication station shown inFIG. 1.

FIG. 3 is a simplified block diagram of a communication station for usewith an infusion device, glucose monitor, glucose meter and a personalcomputer in accordance with an embodiment of the present invention.

FIG. 4 is a simplified block diagram illustrating a basic software flowstructure used by an embodiment of the present invention.

FIG. 5 is a perspective view of an infusion pump mounted in the cradleof the communication station shown in FIG. 1.

FIG. 6 is a perspective view of a glucose monitor mounted in the cradleof the communication station shown in FIG. 1.

FIG. 7 is a view of a General User Preferences display screen used bysoftware in accordance with an embodiment of the present invention.

FIG. 8 is a view of a Report User Preferences display screen of used bysoftware in accordance with an embodiment of the present invention.

FIG. 9 is a view of a Clinic Info User Preferences display screen ofused by software in accordance with an embodiment of the presentinvention.

FIG. 10 is a view of a Sensor Labels User Preferences display screen ofused by software in accordance with an embodiment of the presentinvention.

FIGS. 11( a)-11(d) show views of various menus used by software inaccordance with an embodiment of the present invention.

FIGS. 11( e)-11(s) show views of icons used as an alternative to themenus shown in FIGS. 11( a)-11(d).

FIG. 12 is a view of a Patient Selection display screen used by softwarein accordance with an embodiment of the present invention.

FIG. 13 is a view of a Patient Entry and Edit display screen of used bysoftware in accordance with an embodiment of the present invention.

FIG. 14 is a view of a Report display screen used by software inaccordance with an embodiment of the present invention.

FIG. 15 is a view of a Current Pump Setup display screen used bysoftware in accordance with an embodiment of the present invention.

FIG. 16 is a view of a Log Book display screen used by software inaccordance with an embodiment of the present invention.

FIG. 17 is a view of a Daily Summary display screen used by software inaccordance with an embodiment of the present invention.

FIGS. 18( a)-(c) are views of a Daily Detail display screen used bysoftware in accordance with an embodiment of the present invention.

FIGS. 19( a)-(d) are views of a Weekly Summary display screen used bysoftware in accordance with an embodiment of the present invention.

FIGS. 20( a)-(b) are views of a Weekly Detail display screen used bysoftware in accordance with an embodiment of the present invention.

FIGS. 21( a)-(b) are views of a 2 Week Modal Day display screen used bysoftware in accordance with an embodiment of the present invention.

FIGS. 22( a)-(b) are views of a Sensor Details display screen used bysoftware in accordance with an embodiment of the present invention.

FIGS. 23( a)-(f) are views of legends and symbols used in the reportsgenerated by software in accordance with an embodiment of the presentinvention.

FIG. 24 is a view of a Data Summary display screen used by software inaccordance with an embodiment of the present invention.

FIG. 25 is a view of a Current Settings display screen used by softwarein accordance with an embodiment of the present invention.

FIG. 26 is a view of an Event Log I display screen used by software inaccordance with an embodiment of the present invention.

FIG. 27 is a view of a Daily Log Book display screen used by software inaccordance with an embodiment of the present invention.

FIG. 28 is a view of an Event Log II display screen used by software inaccordance with an embodiment of the present invention.

FIG. 29 is a view of an Event Log III display screen used by software inaccordance with an embodiment of the present invention.

FIG. 30 is a is a perspective view illustrating a subcutaneous glucosesensor insertion set and glucose monitor device embodying the novelfeatures of the invention;

FIG. 31 is an enlarged longitudinal vertical section taken generally onthe line 2-2 of FIG. 30.

FIG. 32 is a simplified block diagram of a communication station for usewith an infusion device, glucose monitor, glucose meter and a personalcomputer in accordance with another embodiment of the present invention.

FIG. 33 is a simplified circuit schematic of a communication station inaccordance with yet another embodiment of the present invention.

FIG. 34 is a generic view of an LCD for use with the embodiment of thecommunication station shown in FIG. 33.

FIG. 35 is a menu screen view of an LCD for use with the embodiment ofthe communication station shown in FIG. 33.

FIG. 36 is a alphanumeric screen view of an LCD for use with theembodiment of the communication station shown in FIG. 33.

FIG. 37 is a softkey screen view of an LCD for use with the embodimentof the communication station shown in FIG. 33.

FIG. 38 is a check screen view of an LCD for use with the embodiment ofthe communication station shown in FIG. 33.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in the drawings for purposes of illustration, the invention isembodied in a communication station for use with an infusion device forinfusion of a liquid, such as medication, chemicals, enzymes, antigens,hormones, vitamins or the like, into a body of a user; and a computer,such as a personal computer (PC), laptop, computer, processing device,remote computer, other medical device or the like. In preferredembodiments of the present invention, the infusion device is an externalinfusion pump; however, it will be recognized that further embodimentsof the invention may be used with programmer or data transfer devicesfor use with external infusion pumps, implantable administrationdevices, implantable infusion pumps, or the like, or systems that use acombination of implantable and external components. Particularembodiments are directed towards the use in humans; however, inalternative embodiments, the infusion devices may be used in animals.The invention is also embodied in a communication station for use with aglucose monitor system that is coupled to a sensor set to providecontinuous, near continuous, or intermittent data recording of thesensor readings for a period of time. In preferred embodiments of thepresent invention, a glucose sensor and a glucose monitor are used fordetermining glucose levels in the blood and/or bodily fluids of theuser. However, it will be recognized that further embodiments of theinvention may be used to determine the levels of other analytes oragents, characteristics or compositions, such as hormones, cholesterol,medications concentrations, viral loads (e.g., HIV), or the like. Inother embodiments, the glucose monitor may also include the capabilityto be programmed to take data at specified time intervals or calibratedusing an initial data input received from an external device. Theglucose monitor and glucose sensor are primarily adapted for use insubcutaneous human tissue. However, still further embodiments may beplaced in other types tissue, such as peritoneal, inter-peritoneal,intraperitoneal, dermal, sub-dermal, subdural, intrathecal,intraventricular, muscle, lymph, organ tissue, veins, arteries or thelike, and used in animal tissue. Embodiments may record sensor readingson an intermittent or continuous basis.

As illustrated in FIGS. 1-3 and 32, a communication station 10 is usedwith an infusion pump 12 to transfer data and information to and from apersonal computer (PC) 14. In preferred embodiments, the communicationstation 10 is connected to the PC 14 through a wired connection to acommunication port 16. However, in alternative embodiments, the personalcomputer may be connected by a wireless connection, a computer network,by modem, or the like. In addition, the PC 14 may be a laptop computer,another medical device with processing capabilities, or the like. Inaddition, the communication station 10 may work with devices other thanan infusion pump 12, such as sensor devices (e.g., a glucose monitor18), glucose meter 24 or other electronic medical devices. In addition,the communication station may be able to work with different infusionpumps 12 and/or multiple devices at the same time using one or more ofthe other ports or additional ports.

In preferred embodiments, the infusion pump 12 is connected to thecommunication station 10 through a cradle holder 20 on the communicationstation 10 that maintains the position and orientation of the infusionpump 12. This permits the infusion pump 12 to interface with thecommunication station 10 using an optical communication connectionhaving optical elements 22. In alternative embodiments, the infusionpump 12 may be connected using other methods, such as wired connections,radio connection, contact connections, or the like. In furtherembodiments, the portion of the communication station 10 that includesthe cradle 20 may be replaceable to permit the cradle 20 to bereconfigured to work with other medical devices, such as a glucosemeter, RF programmer or data transfer device. In still furtheralternative embodiments, the optical elements may also be reconfiguarbleto work with different devices.

As shown in FIGS. 1-3, preferred embodiments of the communicationstation 10 are designed to work with the MiniMed® model 507, 507C, 508infusion pumps and future generation infusion pumps by allowingcommunication between the infusion pumps 12 and a PC 14, laptop, remotecomputer, data processor, or the like. The software, provided ondiskettes or CDs with the communication station 10, will retrieve storedinfusion data from the infusion pumps 12 and provide several reports.The reports include text, graphics and key statistics useful for dataanalysis and interpretation. The user can also download glucosemeasurement and event data from the MiniMed continuous glucose monitor18 model MMT-7101 and 7102, and glucose meters 24 such as the Lifescan:One Touch Profile and One Touch II, and the Roche Diagnostics: Accu-chekcomplete, Accu-chek advantage, and Accu-chek easy. However, inalternative embodiments, the communication station 10 may be used withother infusion pumps, such as those produced or proposed by Disetronic,Animas, or the like, continuous glucose monitors proposed by Therasense,SpectRX, or the like, and glucose meters, such as those made or proposedby Bayer Corporation (such as Glucometer DEX, Glucometer Elite, or thelike), Abbot Medisense (such as the Precision QID, or the like), MercuryDiagnostics, or the like. The communication station 10 allows access tothe internal memories of the devices specified above. In preferredembodiments, the communication station 10 and software communicates withonly one device at a time. However, in alternative embodiments, thecommunication station 10 and software may communicate with more than onedevice at a time.

As shown in FIGS. 3 and 32, to communicate with the infusion pump 12 (orglucose monitor 18 or meter 24), the communication station and softwareuses a combination of RS-232 and infrared links. An RS-232 cable throughport 16 connects the PC 14 to the communication station 10 and thecommunication station 10 uses an infrared communication link 22 to theinfusion pump 12 (or glucose monitor 18). The device (infusion pump 12,or glucose monitor 18) must be placed on the communication station 10 inorder for the software to communicate with the device. To communicatewith most glucose meters 24, the communication station 10 and softwareuses two RS-232 links 16 and 26. The glucose meter 24 is connected to anadditional RS-232 port 26 on the communication station 10 and thecommunication station 10 merely functions as a ‘pass through’ connectionbetween the PC 14 and glucose meter 24. A manually operated switch onthe communication station makes this connection. In alternativeembodiments, the switch may be automatically activated, such as bydetection of a connection with an appropriate device or by a commandgenerated in the PC software. The communication station 10 will enhancecommunication between a patient and a doctor by allowing the doctor toretrieve glucose monitor data and data regarding the patient's infusionpump usage.

As shown in FIGS. 1-3 and 32, the communication station 10 includes thefollowing components (see FIGS. 1 and 2). an On/Off Switch 30—The switchis marked by two symbols “O” indicating the device is OFF and “I”indicating the device is ON. A green light 34 illuminates when thecommunication station is ON. An infusion pump “Cradle” 20—A depressionin the communication station where the infusion pump 12 (and/or glucosemonitor 18) is placed to download data stored in its memory. The cradle20 contains infrared (IR) ports 22, which provide a communication linkbetween the infusion pump 12 or glucose monitor 18 and a PC 14 and allowa data download to occur. An AC Adapter Port 32—provides the powersupply connection to the communication station. Communication Ports (ComPorts) A and B 16 and 26—using a computer cable, provide a data linkbetween the communication station 10 and a PC 14 (Port A—16) or a memoryglucose meter 24 (Port B—26). A Device Selector Switch 28—selects a datadownload from either a MiniMed infusion pump 12 or a memory glucosemeter 24 (B). A push-button or rocker selector 28 switch will selectbetween IR communication 22 (COM Port A connected to IR) and COM Port B26 (COM Port A connected COM Port B). Preferably, the PC software willnot control the selection of using either the IR port 22 or secondRS-232 port 26. However, alternative embodiments may include a remotesetting switch that allows for remote selection of whether the IR port22 or the second RS-232 port 26.

The communication station 10 shall be designed to ensure that the IRports 22 are insensitive to ambient light so that the presence ofambient light will not cause a device malfunction by interference withthe IR communication transceivers 22. When infusion pump 12 is placed inthe communication station 10 cradle 20, two (2) infrared (IR) ports (notshown) on the back side of the infusion pump 12 align with two (2) portson the communication station 10. Data is then transferred from theinfusion pump 12 using these IR ports 22. Preferably, the communicationstation 10 uses at least two Infra-Red (IR) communication transceiversets 22 on each communication station 10. One IR transceiver set 22 ispositioned to communicate with the infusion pumps 12 described above,and the other one IR transceiver set 22 is positioned to communicatewith the glucose monitor 18.

The communication station 10 will also have two RS-232 compatible serialcommunication ports 16 and 26; one female DB9 (To PC) 16, which isidentified as COM Port A, and one female DB9 (pass-through) 26, which isidentified as COM Port B. In preferred embodiments, a serial cable toconnect the communication station to the PC 14 will be provided with thecommunication station 10. The cable will have a female DB9 end toconnect to the PC 14 and a male DB9 end to connect to the communicationstation 10 (COM Port A—16). In alternative embodiments, the male andfemale connectors of the communication station and the cable may beinterchanged.

The communication station 10 will use a microcontroller 34 to supportthe communication between the infusion pump 12 or glucose monitor 18 andthe PC 14. Preferred embodiments of the communication station 10software will include circuitry, modems or the like, that supportscommunication at baud rates from 1024, 1200 up to 19200 Baud. However,in alternative embodiments, lower rates to 100 Baud and higher rates toseveral MegaBaud may be used, with the selection being dependent on thetype, the amount of data, and the location that the data is downloadedto.

There will be firmware (embedded software) used in the communicationstation 10. This firmware will contain the means to supportcommunications with the infusion pump 12 or glucose monitor 18 and oftranslating to serial information. In preferred embodiments,communication protocols necessary to communicate with the infusion pump12 or glucose monitor 18 will be contained in the communication station10 firmware. However, in alternative embodiments, the communicationprotocols may be loaded into a RAM, other suitable memory device, a CD,or the like.

Preferably, the communications link with the infusion pump 12 or glucosemonitor 18 will not be initiated by the communication station 10firmware until communications with the PC software has been establishedand the appropriate command has been received. Preferably, the softwareto communicate to the communication station 10 will reside in the hostPC 10. However, in alternative embodiments, the software may reside inthe communication station 10, infusion pump 12, glucose monitor 18and/or glucose meter 24. The PC software will establish thecommunication link with the communication station 10. The PC softwarewill send the commands to initiate the downloading of the appropriatedata to a text file which will be stored on the PC 14. It will alsocreate reports and graphs. In alternative embodiments, a remote computermay be utilized to establish a communication link and may request userconfirmation at the communication station to confirm the establishmentof the communication link. The PC software will be Windows95-compatible. However, alternative embodiments may be compatible withfuture versions of Windows, UNIX, LINUX, DOS, Mac OS, OS2, or the like.

Preferably, the communication station shall not require any calibration.In addition, other than periodic cleaning of the device, no maintenanceshall be required particularly in the area of the infra-red components.It is critical to the operation of the communication station 10 that theinfra-red clear lenses protecting the receiving and transmittingelements 22 be maintained in an optically clear condition. Thecommunication station 10 shall be designed to allow cleaning with a softcloth or paper towel and commonly used household and clinical cleansingagents. Cleaning requirements and chemical resistance will conform toAAMI TIR No. 12-1994 Annex A.

As shown in FIGS. 3 and 32, to use the communication station 10, connectthe communication interface cable, which is supplied with thecommunication station 10, into either the “COM 1” or “COM 2” connectorof the PC 14. Connect the other end of the Communication Interface Cableto the “COM A” port 16 of the communication station 10. Connect thepower cable with AC Adapter 36 into to the communication station 10 andconnect the other end to a power source. Depress the power switch 30 sothat it points to “l”. A green light 34 on this switch 30 will glow whenthe communication station 10 is receiving power and is turned ON. Withthe connections established and power supplied, the communicationstation 10 is now ready to download the data stored in the infusion pump12 or glucose monitor 18. Alternative embodiments may utilize other PCcommunication architectures including, but not limited to, SCSI,network, IR links, or the like.

Press the Device Selector Switch 28 on the communication station 10 toindicate that a cradle 20 loadable device will be used. Place theinfusion pump 12 face up (so that you are looking at the infusion pumpdisplay) into the communication station 10 cradle 20 (see FIG. 5). Makesure that the infusion pump 12 is lying flat and snugly in the cradle20. This will line up the IR communication ports of the infusion pump 12and the IR communication ports 22 of the communication station 10. If aglucose monitor 18 is to be used, the glucose monitor 18 is seated inthe cradle 20 (see FIG. 6). The infusion pump (or glucose monitor 18)can now be accessed by the PC software on the PC 14.

FIG. 4 illustrates the basic system flow for the PC software used tocontrol the communication station 10. The software starts with a splashscreen 52 to inform the user of the software title and version. Next theuser selects either an existing patient data file 54 or creates a newpatient data file 56. After selection of the appropriate data file, theuser selects whether to download new information 58 or to generatereports 60 based on previously downloaded data. The following sectionswill discuss the various software functions, screens and reports.

As discussed above, the software on the PC 14 will display a SplashScreen 52 after opening the application. The Splash Screen 52 willinclude the following characteristics: logo, such as the MiniMed logo,or the like; title, such as “Communications and Data Analysis SoftwareVersion x.x”, or the like; subtitle, such as “For Use with MiniMed 507,507C, and 508 Insulin Pumps, MiniMed Glucose Monitor 7101 and 7102, andGlucose Meters (Accuchek, OneTouch)”, or the like; additional subtitlessuch as “Copyright YYYY/MiniMed Inc./All Rights Reserved”, or the like;and a button such as “OK”, or the like, to indicate an understanding ofthe window. In alternative embodiments, more or less information and/orbuttons may be added to the splash screen 52.

When the user initiates the software for the first time, or needs toreconfigure the software to reflect changes in the medical device,patient information, or the like, the user accesses the User PreferencesScreen, as shown in FIGS. 7-10, through a menu such as shown in FIG. 11(a). This User Preferences Screen allows the user to setup variousparameters and data for the facility and parameters that are common toall patients. The User Preferences screen consists of four parts, orsub-screens: General (FIG. 7), Reports (FIG. 8), Clinic Info (FIG. 9),and Sensor Labels (FIG. 10). Additional preferences and screens may beused, with the selection being dependent on the software requirements,the user's needs and the type of data analysis to be performed.

As shown in FIG. 7, the General screen allows the input of: Com Portselection (i.e. Com1, 2, 3, or 4) to use with the communication station10, Language Selection (American English, Int. English, Dutch, French,German, Italian, Spanish, and Swedish) to use for communicating with theuser of the software, selection of ‘Mandatory Patient ID’ to identifyeach patient, selection of the Patient ID Length to use with thesoftware, and specification of whether Patient ID is to be the patient'sSSN (i.e., social security number).

As shown in FIG. 8, the Reports screen allows the input of: enabling ofspecific Quick Reports (including Current Settings, Pump History, DailySummary, Daily Detail, Weekly Summary, Weekly Detail, Modal Day, &Sensor Details), specification of Hyperglycemic and Hypoglycemic limits,and selection of the units to be used for the meter measurements.

As shown in FIG. 9, the Clinic Info screen allows the input of clinicalinformation including: Clinic Name (or name of the medical office,hospital, or the like), the Address, the physician (or internist,endocrinologist, clinician, or the like), and the Phone Number.

As shown in FIG. 10, the Sensor Labels screen allow the specification ofnames of Sensor Labels associated with and representative of variousglucose monitor events inputted by the user.

To use the communication PC software requires the selection of a patientunder which to download data and/or analyze data. To select a patient,the user will click on the appropriate patient name that is listed in aPatient Selection window, such as shown in FIG. 12. If there is nopatient, or if another patient record is required, the user will need tocreate a new patient record to associate downloaded data with thatpatient (or another patient selected before downloading). FIG. 11( b)shows an example of a menu that is used to access a Patient Entry andEdit screen. Alternatively, the user may click on the icon in FIG. 11(e) for a new patient or the icon of FIG. 11( f) for editing an existingpatient. FIG. 13 shows the Patient Entry & Edit screen used to create anew patient record or edit existing information in a patient record. ThePatient Entry & Edit screen allows entry and editing of patient name,patient ID (such as a unique number, social security number or the like)and infusion pump type (e.g., brand and model number). As shown in FIG.13, the screen also allows entry and editing of individual patienthyperglycemic and hypoglycemic levels, and permits the user to selectglucose levels to be displayed in either Mg/dL or mmol/L, without thenecessity of the user going to the User Preferences window. Inalternative embodiments, the Patient Entry & Edit screen may also beused for the input of additional information, such as glucose monitorinformation, glucose meter information, additional patient specificinformation, or the like. Some information is inputted by typing in theinformation, some by selecting from a list. In alternative embodiments,the information may be inputted by other methods, such as checking offselected parameters or by toggling a softkey on the screen. If aduplicate Patient ID is entered, the PC software will detect this andrequire the user to enter another ID. Alternatively, software maydetermine duplication on the patient's name, or the like.

As shown in FIG. 11( b), the software shall also allow the user todelete individual patients and all data associated with those patients.This is accomplished by selecting the patient from the list shown inFIG. 12, and then selecting delete on the menu in FIG. 11( b).Preferably, the software shall require the user to confirm the deletionof the patient record and associated data. Following a successful deletedata operation, the specified patient name (i.e. the patient selected onthe Patient Selection screen) will no longer appear on the PatientSelection screen. In alternative embodiments, the information for thatpatient will be maintained for possible later recall, or sent to a longterm data storage area. In that situation, to actually delete specificinformation may require the use of a special screen or additionalprogram. In alternative embodiments, the use may select the icon 11(g)instead of the menu 11(b)

Once a patient record has been created, the Patient Selection screen, asshown in FIG. 12, is used to specify a patient for subsequentoperations. Before a new device data can be downloaded or before anyreport can be viewed, the user must first select a patient. To select apatient from a list, the patient name portion of the selected patient ishighlighted. In addition, subsequent edit patient, delete patient,download and report display operations shall be for this selectedpatient until another patient is selected. Preferred embodiments of thePatient Selection screen format include the following displayedinformation for each patient such as Patient name, Patient ID, PumpType, and Date of most recent download. The list of patients on thePatient Selection screen is preferably sortable by any of the displayedinformation such as Patient name, Patient ID, Pump Type, or Date. Inalternative embodiments, the Patient Selection screen may include otherinformation such as glucose monitor type, glucose meter type, doctor,facility, or the like, and may be sortable by this additionalinformation. If a patient uses more than one type of infusion pump,glucose monitor, glucose meter, or the like, so that a patient has ahistory of downloads from at least two different devices, such as both507 and 507C infusion pumps, only the most recently device (e.g., a 507Cinfusion pump) downloaded shall be displayed on the screen.

The download operation consists of transferring data to the PC 14 (orother data storage and/or processing device) from the following medicaldevices such as infusion pumps 12, monitors 18, and meters 24. Todownload data from a medical device, the user can select the appropriatemenu under the download heading shown in FIGS. 11( a)-(d), or use theinfusion pump download icon (shown in FIG. 11( i)) to download theinfusion pump 12, the glucose monitor download icon (shown in FIG. 11(j)) to download the glucose monitor 18, or the glucose meter downloadicon (shown in FIG. 11( k)) to download the glucose meter 24. Thedownloaded data will be saved in the currently selected patient's recordin the data base. In alternative embodiments, the user may be able todirect the data to be saved to a different patient record or storagearea. The user shall be notified of any download errors encountered. Ifpossible, the download operation will provide an error recoverycapability, which is particularly useful in conjunction with a lengthydownload operation. Preferably, during the download operation, adownload screen will be displayed with the patient name, device type andmodel number. In addition, a progress bar indicator will be displayed toindicate the status of the download. In alternative embodiments, more orless information may be displayed. Generally, following a successfuldownload operation, the message “Download completed successfully. Savedata?” shall be displayed. The user is then prompted Yes/No.” Thedownload screen will permit the user to cancel the download operation,either during the download operation or prior to the final saving of thedata.

Downloading for infusion pumps includes the process of transferringappropriate data from the infusion pump 12 to the PC 14. Typical storedinformation, which is downloaded from an infusion pump 12 are currentpump settings, daily totals and boluses, events, and alarms. Thedownloaded infusion pump data is integrated in the reports with glucosemonitor 18 and glucose meter 24 data that has been previously or laterdownloaded (see discussion below). The infusion pump download operationwill be initiated by either the Pump Download icon (see FIG. 11( i)) orvia the menu bar (see FIGS. 11( a)-(d)). Preferably, the infusion pumpdownload operation automatically determines the infusion pump modelnumber (e.g. 507, 507C or 508, or the like) and uses the appropriatecommunication protocol for the particular infusion pump. Generally, thetransfer time runs from several seconds to 20 minutes, with the timebeing dependent on the type of infusion pump, and the amount and thetype of data stored in the infusion pump. In preferred embodiments, theuser will be prompted to verify infusion pump settings followingcompletion of the download. Specifically, the AutoOff duration should bereset and Suspend of the infusion pump should be canceled. In addition,after successfully completing the download operation, the downloadedinfusion pump data will be integrated with any previously downloadeddata for the specified patient. In alternative embodiments, the user maybe given the option to replace or discard the previous data with thenewly downloaded data, or the ability to only integrate portions of thedata based on dates, times, type of data, or the like.

The communication station PC software checks for several differencesduring the download operation. For instance, the software checks for aTime/Date difference during the download operation by comparing the timeand date in the infusion pump 12 with the time and date in the PC 14. Ifa difference of >5 minutes exists, the user will be notified with amessage indicating the existence of the mismatch and the time and datefor each device. The user then will be asked to select which time anddate should be used and given the option to reset the time and date onthe infusion pump. In alternative embodiments, different timedifferences may be used to prompt the user. The PC software also checksfor an infusion pump serial number difference between the previousdownload, and then if noted, the software will alert the user and offerthe options of either CANCEL or PROCEED. In addition, the software willcheck for a time overlap, such as by a clock change, and then if it isnoted, the program shall offer the following options: CANCEL download,PROCEED (and discard older overlapping data), PROCEED (and discard neweroverlapping data). Alternative embodiments may check for otherdifferences or changes during the download operation.

Downloading for glucose monitors 18 includes the process of transferringappropriate data from the glucose monitor 18 to the PC 14. The glucosemonitor download will be initiated from either the Menu bar (see FIGS.11( a)-(d)) or via the glucose monitor download icon (see FIG. 11( j)).Typical stored information, which is downloaded from a glucose monitor18, includes sensor readings, event markers, and manually enteredglucose readings (e.g., for reference and calibration). In alternativeembodiments, more or less data and information may be transferred.Generally, the transfer time runs from several seconds to 20 minutes,with the time being dependent on the type of glucose monitor 18, theamount and the type of data stored in the glucose monitor 18. Theglucose monitor download operation will include an ERROR RECOVERY (theinfusion pump operation may also include this feature) which allows thecommunication station software to retry the download operation if anerror is detected. In addition, after successfully completing thedownload operation, the downloaded glucose monitor data will beintegrated with any previously downloaded data for the specifiedpatient. In alternative embodiments, the user may be given the option toreplace and/or discard the previous data with the newly downloaded data,or the ability to only integrate portions of the data based on dates,times, type of data, or the like.

Downloading for glucose meters 24 includes the process of transferringappropriate data from the glucose meter 24 to the PC 14. The glucosemeter download will be initiated from either the Menu bar (see FIGS. 11(a)-(d)) or via the glucose monitor download icon (see FIG. 11( k)).Typical stored information, which is downloaded from a glucose meter 24,includes time stamped glucose readings, current clock settings, eventmarkers, or the like. Preferably, the glucose meter download operationautomatically determines the glucose meter type and model (e.g. RocheAccuchek Vs Johnson & Johnson One Touch, or the like) and uses theappropriate communication protocol for the particular glucose meter.Generally, the transfer time runs from several seconds to 20 minutes,with the time being dependent on the type of glucose meter, the amountand the type of data stored in the glucose meter 24. In addition, aftersuccessfully completing the download operation, the downloaded glucosemeter data will be integrated with any previously downloaded data forthe specified patient. In alternative embodiments, the user may be giventhe option to replace and/or discard the previous data with the newlydownloaded data, or the ability to only integrate portions of the databased on dates, times, type of data, or the like.

The communication station PC software provides several data display andprint options for the user to better analyze and sort the datadownloaded for each patient. For instance, the PC software providesuser-selectable displays (e.g., reports, and the like) and printouts ofinfusion pump 12, glucose meter 24 and glucose monitor 18 (i.e., sensor)data in accordance with the display screens and reports shown in FIGS.14-29. Preferably, the user shall be provided with the capability ofselecting any display or printout for any period prior to the lastdownload date/time. In particular embodiments, the selected report(display or printout) shall contain up to 91 days of data prior to andincluding the selected download date/time. Note that the report may alsocontain data from a different download date and time to fill the 91 dayperiod. Alternatively, the report may only cover a specific period orfraction within the downloaded data or may include more or less than 91days.

FIG. 14 illustrates the general display structure used by the reportsgenerated by the software. The report form will include a CLOSE CommandButton that undisplays (removes) the individual report when the user isdone with that report. The report form will display a Help menu toprovide context-sensitive help for the selected report (see FIG. 11(d)). If the report includes more than one screen, arrow buttons(generally located at the bottom of the screen) will provide for movingback and forth between the multiple screens.

A report is selected for display via either the standard Windows menu(e.g. under reports—see FIG. 11( c)) or via the communication station 10toolbar (using report icons—see FIGS. 11( l)-11(s)). The active-inactivestate of a toolbar icon is context sensitive to the patient's specificinfusion pump type, glucose monitor type, and glucose meter type.Accordingly, some Report Icons (and menu selection options) are inactivefor some infusion pumps, glucose monitors and glucose meters. It shouldbe noted that additional reports may be generated, with the followingreports serving to illustrate various reporting abilities. During thereport generation process, the following labels (see FIG. 23( a)) may beused to express various data status issues:=‘Inc’=incomplete data (thereis some data but it is clear that some data is missing); ‘N’=no data ispresent; ‘T’=a time change has occurred w/o overlap; and ‘O’=a timechange has occurred with overlap. In addition, where appropriate, thex-axis shall be displayed in either a 12 or 24 hour format depending onthe User Preference screen setting. FIG. 14 illustrates and describesvarious other aspects of the general report screen. Although not shownin these reports, the reports may also include facility information suchas Physician Name, Address (facility), and Phone Number (facility).

FIG. 15 illustrates the Patient Information/Current Pump SettingsReport, which is selectable by the icon shown in FIG. 11( l). Thisreport will have the following components:

-   -   1) the Device Table section lists the devices that have been        previously downloaded into the selected patient's file. The        table includes for each previously downloaded device: the device        name, serial number, and most recent download date. The devices        listed in the Device Table shall be: infusion pump(s),        monitor(s), and meter(s). For each device type (e.g. infusion        pump), there may be either none, one, or multiple instances        listed. Preferably, this section of the report shall be of        variable length and shall be scrollable. If infusion pump data        is present, the infusion pump settings listed in report shall be        displayed at the bottom of the report. If multiple infusion        pumps are listed, the settings of only the infusion pump most        recently used shall be displayed.    -   2) the Current Basal Profile section, if infusion pump data is        present, will show the current 24 hour Basal Profile as a        continuous line and/or bar graph over 24 hours. Units/hour shall        be depicted on the Y axis, with the values preferably        automatically scaled with the highest value equal to the next        highest whole unit above the highest basal rate setting. In        addition, it is preferred that the time in hours will be        depicted on the x axis with 12 am, 3 am, 6 am 9 am, 12 noon, 3        pm 6 pm, 9 pm and 12 am markers indicated. Also, faint        horizontal lines will be present across the graph at 0.2 unit        increments up to a maximum of 5.0 units/hour. If the total        exceeds 5.0 units, the scale will switch to 0.5 unit increments.        Other units, time values or axis labeling may be used.    -   3) statistics on the profile will also be provided and include        the number of basal rates (rates/day), the total basal insulin        (U/day), the date the basal rate was last changed (date), and        the umber of days since the profile was changed.

The software shall have the ability to display Current Infusion PumpSetup information as shown in Table 1 below:

TABLE 1 Pump Setting Display Format Parameter Units Range Auto OffHr—Hour Off, Hour setting Beep Volume N/A 1, 2, 3 Audio Bolus U—UnitsOff, or ‘increment step level’ Variable Bolus N/A On, Off Max BolusU—Units 0.0-25.0 Units Max Basal U/H—Units per hour 0.0-35.0 Units perhour Time Display N/A 12 Hr, 24 Hr Insulin N/A U40, U50, U100Concentration

FIG. 16 illustrates the Log Book report, which is selectable by the iconshown in FIG. 11( m). This is a chronological report that integratesinfusion pump 12, glucose monitor 18, and glucose meter 24 data. Thereport will provide a vertically scrolling table with 3 columns(Date-Time of data entry, Item explaining data, and Value of data) for auser specified period. Generally, this is for the most recent 91 days ofdata in descending order; however, longer or shorter periods may beused. The user may tailor the content using the check boxes listed onthe side of the report, and which are segregated by Pump, Meter andSensor (or Monitor). Check boxes shall be provided to allow the user toselect any combination of the following items to display in the table:Pump Data includes bolus history, prime history, daily insulin totals,alarms, programming events, and basal profile changes; Glucose Meterdata includes glucose measurements and excursions; and glucose monitordata includes sensor data, sensor summary (mean, minimum and maximum foreach hour of sensor use), sensor excursions (all sensor values outsidelimits hourly sensor summary defined in the User Preferences screen),sensor data (every sensor reading, at 5 min intervals), sensor eventmarkers (with labels as defined in specified patient User Preferencesscreen). In alternative embodiments, other parameters may be providedand selected.

FIG. 17 illustrates the Daily Summary report screen, which is selectableby the icon shown in FIG. 11( n). This report provides a summary ofinformation relating to the glucose data status and insulin data statusfor a particular day. Alternatively, it may provide a report for severaldays in a summary format as shown. The glucose data status section showsthe number of readings, the average glucose value and the range. Theinsulin data status section shows total amount of insulin taken, thenumber of boluses, the prime volume, the percent of the time that atemporary basal rate was used, and the percent of time that the infusionpump operation was suspended. This report is similar to the report shownin FIGS. 19( a)-(d) below, but summarizes on a daily basis rather than aweekly basis.

FIGS. 18( a)-(c) illustrate the Daily Details report screen, which isselectable by the icon shown in FIG. 11( o). This report provides adetailed daily view of each of up to 91 days of infusion pump, glucosemeter, and sensor (e.g., monitor) data. Each screen represents a singleday's data and consists of the following components: infusion pump data(i.e., insulin usage data), sensor and meter data (i.e., glucose data),alarm/event/marker table, and pie charts (basal:bolus ratio and bolustype).

The infusion pump data is shown in the upper section and graphicallydepicts basal rate, bolus, prime, and alarm history for the specifiedday. The basal rate is shown as a line indicating: normal basal rate,temporary basal rate, auto-off, and suspend (preferably, the programmednormal basal rate shall be shown as a dashed line during any of:suspend, temporary basal rate, or auto-off). Boluses will also beindicated. The alarm markers will be positioned to show the time of anyalarm. In the illustrated report, two insulin scales are marked due tothe relative scale of a bolus (large) compared to a basal rate (small).The bolus scale shall be on the left y-axis and the basal scale shall beon the right hand y-axis. In particular embodiments, any priming eventswill also be shown.

The sensor and meter data is shown in the lower section and graphicallydepicts meter readings and sensor data-vs.-time for the specified day.Preferably, any continuous glucose monitor (i.e., sensor) readings willbe displayed as a continuous line graph. Meter readings will be markedas either a reference value or as calibration points. Any sensor eventmarkers, such as small rectangular markers, or the like, at the bottomedge shall depict sensor event markers.

The alarm/event/marker table is shown in an upper side section and willbe shown only if either infusion pump 12, glucose meter 24 or glucosemonitor 18 (i.e., sensor) data is present. Alarms and events from theinfusion pump 12, glucose meter 24 and glucose monitor 18 will be listedin order of time of the event/alarm. Textual definitions for eventsshall be listed if defined; otherwise a numeric value for the eventsshall be shown. This table shall display the following ‘programmingchanges’ for the current day: Time/Date change—displays new date (inmm-dd-yy format) and new time, where the time change is displayed ineither 12 or 24 hr format depending on user's settings; SuspendOn/Off—time the feature was turned on and was time turned off; Temporarybasal rate—displays setting of a Temporary Basal Rate including amountin units per hour (e.g. 0.6 u/h) and duration displayed in same formatas duration for bolus history; Basal Rate change—a note referring to aBasal Profile section for basal rate change history; batteryremoval/replacement—displays the removal and subsequent replacement ofbatteries with time of action; Maximum Basal Rate change—changes of thesetting along with the time of action; Maximum Bolus change—displays thechange of setting along with the time of action; Insulin Concentrationchange—displays the change of concentration; Auto Off Change—displaysnew feature setting along with the time of change displayed in hours;Alarm/Error Code—brief description of the alarm/error.

The pie chart data is shown in a lower side section and graphicallydepicts basal:bolus ratio and bolus type as pie charts.

FIGS. 19( a)-(d) illustrate the Weekly Summary report, which isselectable by the icon shown in FIG. 11( p). This report provides 13weekly summaries of meter and pump data followed by a 91 day summary ofthe entire period. Each weekly column is composed of 2 verticalsections: Monitor and Meter Data (Glucose Data Status) and Infusion PumpData (Insulin Data Status) using both tabular and graphical formats. Asdiscussed above, this report is similar to the Daily Summary reportshown in FIG. 16.

The Weekly Summary report is be split between two screens with 7 weekson the first screen and 6 weeks on the second screen. In addition, a 91day summary column will follow the 13th week on the second screen.Preferably, the report will arrange data and graphics into a tableformat with one row for each data category and one column for each week.The most recent week's data (i.e. ‘column’) shall be on the left withprior weeks to the right. In alternative embodiments, other data formatsor orders of presentation may be used.

Each week's data (i.e. column) shall consist of:

-   -   1) tabular monitor and/or meter data including the average        number of meter readings per day (numeric); glucose goals        (numeric): percent that are above the hyperglycemic limit,        percent that are in range, and percent that are below        hypoglycemic limit (as set in the User Preferences screen);        standard deviation of the week's meter readings (numeric);        average glucose value (i.e. the average meter reading)        (numeric); and a graphic component that shows the glucose        reading range (e.g., a narrow vertical rectangle), average        glucose value (e.g., a diamond within the rectangle), and the        hyperglycemic and hypoglycemic limits (e.g., shown as 2 dotted        horizontal lines). In alternative embodiments, other data        formats or orders of presentation may be used.    -   2) Tabular infusion pump data including the average Daily total        insulin (numeric); average number of boluses per day (numeric);        average prime volume (numeric); the percent of the time that a        Temporary Basal rate is used (numeric); the percent of the time        that the infusion pump was in the Suspend mode (numeric); and a        graphical component including total insulin, basal insulin,        bolus insulin in a stacked column chart, with basal amount on        the bottom including the percent of insulin delivered by basal        rate (numeric), and the graphic also shows the average daily        total insulin for the 13 week period as a horizontal dotted line        with associated numeric value. In alternative embodiments, other        data formats or orders of presentation may be used.

FIGS. 20( a)-(b) illustrate the Weekly Details report, which isselectable by the icon shown in FIG. 11( q). This report provides a 14day graphical view of infusion pump data (bolus & primes) and glucosemeter (but not sensor) readings. The screen is split evenly between 2screens with 7 days on each screen, and each screen having a first rowwith 4 days and a second row with 3 days. Data and graphics are arrangedin a table format with one row for each data category (e.g. infusionpump boluses and primes, or glucose meter data) and one column for eachday. Additionally, pie charts of infusion pump and glucose meter dataare displayed. In alternative embodiments, glucose monitor (sensor) datamay be included, and/or a legend explaining the symbols used may beprovided on the screen. Preferably, the most recent date (e.g., column)shall be on the left with prior dates to the right.

The infusion pump data includes the boluses and primes covering a 14 dayperiod. Generally, the basal profile is not included since this is notchanged frequently, but alternative embodiments could include it as partof the report. The data should include an insulin scale that is markedin units, and each bolus and prime should be indicated against thisscale.

The glucose meter data is a plot of meter readings that covers thespecified 14 day period. Preferably, the readings are plotted against aglucose scale of 20 to 240 (although other limits may be used). Thehyperglycemic and hypoglycemic limits (set in the User Preferencesscreen) will be displayed as horizontal dotted lines. In particularembodiments, the numeric values of the limits shall be displayedadjacent to the lines. Any off the scale readings, such as those greaterthan 240 will be indicated at the upper edge of the Meter Data graph bya ‘triangle’ and a numeric value.

The pie charts will include 3 pie charts that each covers 7 days ofinfusion pump and glucose meter data. The Glucose Goals chart includesthree sections that show the percentage of glucose meter readings thatwere above, within, and below range. The Basal/Bolus ratio chartincludes two sections that shows the percentage of total basal insulinand total bolus insulin. The Bolus Type chart includes two sections thatshow the percentage of bolus volume that was delivered by a Normal Bolusand a Square Wave Bolus volume. In preferred embodiments, any dualboluses are split into the Normal Bolus and Square Wave Boluscomponents. However, in alternative embodiments, the dual boluses may beincluded as a separate section of the pie chart.

FIGS. 21( a)-(b) illustrate the 2 Week Modal Day report, which isselectable by the icon shown in FIG. 11( r), This report provides theglucose meter data from a specified 14 days so that it is plotted vs.time on a single day scale so that a user may visualize trends over 2week period as it relates to specific times of day. The user also hasthe option of connecting all of the data from the same day using aconnecting line. In addition, to aid in understanding the data, eachday's data (i.e. multiple points) shall have a unique color, and anyconnecting lines (when present) shall also be color coded to match thecolors of points. The hypoglycemic and hyperglycemic limits (set in theUser Preferences screen) will be shown as horizontal dotted lines. Also,the 14 day mean value of meter readings shall be shown as a horizontaldotted line.

The 2 Week Modal Day report will also have a tabular Statistical Datasection that will include the date range (e.g., the total span of datesdisplayed), number of days displayed, Mean Glucose Level for theselected period, Standard Deviation of the glucose meter readings,Average number of meter readings per day. The 2 Week Modal Day reportwill also include a Glucose Goals pie chart having three sections thatshow the percentage of glucose meter readings that were above, within,and below range for the selected period.

FIGS. 22( a)-(b) illustrate the Sensor Details report, which isselectable by the icon shown in FIG. 11( s). This report depicts GlucoseMonitor data (including meter calibration & reference data) for thespecified 4 day period. The report includes the following components: 1)Continuous Glucose Measurement data (preferably, displayed on a 4 daytime scale.), Modal Day display of Glucose Monitor data displayed on a24 hour scale. In preferred embodiments, the four days of dataimmediately prior to (and including) the specified download date will bedisplayed. However, in alternative embodiments, the user may specifyother time periods. Preferably, calibration and reference data pointswill be integrated with the sensor data and will be differentiated by‘point style’ (i.e. shape of the ‘dot’). Also, each day's sensor datawill be uniquely colored, and a specific day's color in the ‘SensorData’ section will match the corresponding day color in the ‘Modal Day’graph section. In addition, the hypoglycemic and hyperglycemic glucoselimits (set in the User Preferences screen) will be indicated as dashedlines.

The top portion of the report includes the Sensor Data section thatdisplays a 4 day continuous graph of Glucose Monitor data integratedwith meter calibration and reference points. The bottom portion of thereport includes the Modal Day section that displays the Sensor data forthe specified 4 day period so that it is plotted vs. time on a singleday scale (i.e., 4 continuous line graphs of sensor data shall beoverlaid on a single day time scale). The bottom side portion includes aGlucose Goals pie chart that has three sections that show the percentageof glucose meter readings that were above, within, and below range forthe selected 4 day period. The bottom side portion also has a tabularstatistical data section that will include the Hours of Sensor datadisplayed, the Mean Glucose Level for the selected period, the Maximumand Minimum Glucose level for the selected period, the StandardDeviation of the glucose Sensor data, and the average number of meterreadings per day.

As shown in FIGS. 23( a)-(f) various legends, symbols and color codesmay be utilized on the reports. In particular embodiments, the symbolsand color codes may be displayed on the report as a legend to define thegraphical elements used on the report screen. They are also providedhere to further define and clarify the material shown in the reportsdescribed herein.

As described above, the reports are generated and displayed by thecommunication station PC software used by the PC 14 to interpret thedata downloaded from a medical device through the communication station10 to the PC 14. However, the displayed reports may also be printed outfor hard copy records or analysis, such as by the use of a menu or byselecting the icon shown in FIG. 11( h). Preferably, either a singlereport or multiple reports may be printed. In some embodiments, thereports may be faxed or E-mailed to a different location for review by apatient, physician, insurance company, or the like. In preferredembodiments, when the ‘Quick Reports’ operation is initiated under themenu shown in FIG. 11( c), the reports previously specified in the UserPreferences screen will be printed.

FIGS. 24-29 illustrate alternative report screens that can be accessedusing other embodiments of the communication station PC software. Manyof the reports provide information that is similar to that providedabove, but it is presented in different style or format to illustratesome of the possible variations that are available in the reportscreens. The embodiment includes a Main Screen (not shown) that allowsselection of the various reports. This embodiment includes the followingreports: Summary—displays infusion pump summary data; CurrentSettings—displays the current infusion pump settings and basal profile;Daily Log—displays a daily log book of patient data; Event LogI—displays the bolus history, daily totals, and prime history logs;Event Log II—displays the programming events, alarm and basal ratechange history logs; and Event Log III—displays the complete infusionpump history log. The Main Screen also includes a Print Screens buttonthat prints the selected reports.

For these embodiments, each report will have three button options on thebottom of each screen: Main Screen—a single click on this button willreturn the user to the main screen to select another report; PrintScreen—a single click on this button will print the current report; andHelp—a single click on this button will pull up the help files.

FIG. 24 illustrates the Data Summary report which has 5 main sections:the Bolus History section displays the average bolus, the minimum bolus,the maximum bolus and the average number of boluses given per day forthree different time buckets (e.g., 7 days, 30 days and 90 days). TheBasal Rate History section displays the average basal total (i.e., thetotal amount delivered over a 24 hour period), the average basal rate(i.e., the average basal rate delivered per hour), the percent of thetime the infusion pump was suspended and the percent of the time spentin a temporary basal rate for the same three time buckets listed underthe Bolus History. The Daily Total History section displays the averagedaily total of insulin delivered, the average daily rate for insulindelivered, the minimum daily total for insulin delivered, and themaximum daily total of insulin delivered for the three different timebuckets listed under the Bolus History. The Daily Total Graph section isa bar graph which shows the total amount of insulin delivered over thepast 14 days. The bars are “stacked” to show the amount of insulindelivered by basal rate delivery (e.g., bottom of bar) and the amount ofinsulin delivered by bolus delivery (top of bar). Underneath each barthe date is displayed, and the insulin scale is to the left of the graphin units (preferably, these values scale automatically to match theamount that the user has delivered). The Basal/Bolus Ratio Graphs aremade up of three pie charts which show the percent ratio of Bolusdelivery vs. Basal Rate delivery for three time periods. Graph one showsthis ratio for the last seven (7) days, graph two for thirty (30) days,and graph three for ninety (90) days. The ratio appears in text adjacentto each of the sub-sets in the graph. When looking at reports thatdisplay averages for time buckets, if there is not enough data tocomplete a time bucket, for example if only 35 days worth of data isstored in the infusion pump, or the downloaded data, no data will bedisplayed for 90 days bucket. Alternative embodiments will allow theselection of different time periods to be analyzed.

FIG. 25 illustrates the Current Setting report which has two maincomponents: a listing of the current infusion pump settings and a graphof the current basal profile. The current infusion pump settingsincludes information on: Auto Off (OFF or the hour setting if on, e.g.10 hr); Beep Volume (setting level 1, 2 or 3); Audio Bolus (OFF orincrement step level either 0.5 or 1.0 units); Variable Bolus (OFF/ON);Maximum Bolus (0-25 unit setting in units); Maximum Basal rate (0-35unit setting in units/hour); Time Display (12 or 24 hr); and InsulinConcentration (U100, U50, U40). The current basal profile graph is acontinuous bar graph over a 24 hour period. Insulin amounts are shown tothe left of the graph in units/hour (preferably, these valuesautomatically scale to adjust to the individual's basal rate and thehighest value is equal to the next highest whole unit above the user'shighest basal rate setting). The time in hours is depicted across thebottom of the graph 12 am, 3 am, 6 am, 9 am, 12 noon, 3 pm, 6 pm, 9 pmand 12 am markers indicated (if the infusion pump is set in 24 hourformat, the graph will show 24 hour markers). Faint horizontal lines arepresent across the graph at 0.2 unit increments up to a maximum of 5.0units/hour. If the total exceeds 5.0 units the scale switches to 0.5unit increments. The graph's header contains the title “Current BasalProfile” as well as the 24 hour basal total and the number of basalrates currently being used.

FIG. 27 illustrates the Daily Log Book report that allows the user toreview the infusion pump's operation by date. The report displays thefollowing information: Bolus History, Basal Profile, Programming Events,Alarms, Primes and the Daily Total for insulin.

-   -   Bolus History is table that displays the time, type, amount, and        duration of the day's bolus deliveries in chronological order.        The boluses are listed as N for Normal, S for Square, D/N for        the Normal portion of a Dual Wave Bolus, and D/S for the Square        Wave portion of a Dual Wave Bolus. Bolus amounts are recorded in        units, e.g. 6.0 units. Duration times for Square and Dual Wave        boluses are displayed using the following format: a one hour        bolus would be shown as 1:00, a 2 and a ½ hour bolus is shown as        2:30.    -   Basal Profile is a table that displays the current basal rates        set in the pump and the times which each rate starts for the        current day.    -   Programming Events is a table that displays all the programming        changes for the current day beginning at 12:00 am. The possible        programming changes include: Time/Date Change—displays new date        (in mm-dd-yy format) and new time and time of change (a Time        change is displayed in both 12 and 24 hour format depending on        the User Preferences). Suspend ON/OFF—displays the time when        Suspend feature was first turned on and then turned off.        Temporary basal rate—displays a setting of a temporary basal        rate including amount in units per hour, e.g. 0.6 u/h, as well        as time, and duration of the temporary basal rate. Basal rate        change—displays a note referring to Log II to review basal rate        changes. Battery removal/replacement—displays the removal and        replacement of batteries with the time of action. Maximum basal        rate change—displays the change of setting with the time of        action. Maximum bolus change—displays the change of setting with        the time of action. Insulin Concentration change—displays the        change of concentration with the time of action. Auto Off        Change—displays setting along with the time of change displayed        in hours.    -   Alarms is a table that displays the time, alarm/error code and a        brief description of any alarm received for the current 24 hour        period. The following alarms are the most common alarms that the        user may see: A-04—No Delivery; A-05—Depleted Batteries;        A-06—Auto Off; A-35—Motion Sensor; and A-51—Watchdog.        Alternative embodiments may display more or less alarms.    -   Prime History is a table that displays the time and prime amount        in units for the current day. Daily Total is an area that        displays the current day's total insulin delivered as a Basal        and Bolus in units, e.g. 60.0 units as of the time of the        download. To select a different date to review, the user clicks        the “Select Date” softkey button and clicks on the desired date.

FIG. 26 illustrates the Event Log I report that includes threescrollable tables: Bolus History table that shows the date, time, type,amount and duration of all the boluses stored in the infusion pump (Theaverage daily total for the boluses shall be displayed under the BolusHistory table); Daily Total History table that displays the date and thetotal amount of insulin delivered as basal rate plus boluses for up to90 days (the average daily total of insulin shall be displayed under theDaily Total table); and Prime History table that displays the date,amount and time for up to 50 primes.

FIG. 28 illustrates the Event Log II report, which includes threetables: the Programming Event history, the Alarm History, and the BasalRate Change history. Programming Event History—displays the date, timeand type of up to 200 programming events. Alarm History—displays thedate, time and type up to 50 alarms and error codes. Basal Rate ChangeHistory—displays a listing of basal rate changes that have occurredincluding the complete basal profile with date, time and settingchanges. If no basal changes have occurred, no data is displayed.

FIG. 29 illustrates the Event Log III report, which lists all of theinfusion pump operations in reverse chronological order for the past 90days. The last listing for each day is a daily insulin total.

Various modifications may be made to these reports, and they may becombined together in different ways to create custom reports that aresuited to the user's needs. Although various color and graphical schemeshave been presented, other schemes are possible without departing fromthe scope of the embodiments of the present invention. The reports haveemphasized the use of a communication station 10 with an infusion pump12 and augmenting the data with data from a glucose meter 24 and/orglucose monitor 18. However, the communication station 10 and PCsoftware may be used with other medical devices, which then placeparticular emphasis on data from these devices. For instance, thecommunication station 10 may be used primarily with a glucose monitor 18and provide expanded reports beyond those described above. The reportsmay report additional histories and events similar to those describedabove for the infusion pump 12 or in a manner that are particularlysuited to the analysis requirements of the glucose monitor 18 and itsdata.

In that view, as illustrated in FIG. 6, a communication station 10 mayused with a glucose monitor 18 to transfer data and information to andfrom a personal computer (PC) 14. In preferred embodiments, thecommunication station 10 is connected to the PC 14 through a wiredconnection 16. However, in alternative embodiments, the PC 14 may beconnected by a wireless connection, a computer network, by modem, or thelike. In addition, the PC 14 may be a laptop computer, another medicaldevice with processing capabilities, or the like. In preferredembodiments, the glucose monitor 18 is connected to the communicationstation 10 through a cradle holder 20 on the communication station 10that maintains the position and orientation of the glucose monitor 18.This permits the glucose monitor 18 to interface with the communicationstation 10 using an optical communication connection having opticalelements 22. In alternative embodiments, the glucose monitor 18 may beconnected using other methods, such as wired connections, radioconnection, contact connections, or the like.

The glucose monitor system 1001, in accordance with a preferredembodiments of the present invention include a sensor set 1010, and aglucose monitor 18. The sensor set 1010 utilizes an electrode-typesensor 1012, as described in more detail below. However, in alternativeembodiments, the sensor may use other types of sensors, such as chemicalbased, optical based or the like. In further alternative embodiments,the sensors may be of a type that is used on the external surface of theskin or placed below the skin layer of the user. Preferred embodimentsof a surface mounted glucose sensor would utilize interstitial fluidharvested from the skin. Preferably, the sensor 1012 monitors bloodglucose levels, and may be used in conjunction with automated orsemi-automated medication infusion pumps of the external or implantabletype as described in U.S. Pat. Nos. 4,562,751; 4,678,408; 4,685,903 or4,573,994, to deliver insulin to a diabetic patient. However, otherembodiments may monitor other analytes to determine viral load, HIVactivity, bacterial levels, cholesterol levels, medication levels, orthe like.

The glucose monitor 18 generally includes the capability to record andstore data as it is received from the glucose sensor 1010, and thenincludes either a data port or wireless transmitter for downloading thedata to a PC 14, a data processor 200, laptop, communication station, orthe like for later analysis and review. The PC 14, data processor 200,laptop, or the like, utilizes the recorded data from the glucose monitorto determine the blood glucose history. The purpose of the glucosemonitor system 1001 is to provide for better data recording and testingfor various patient conditions utilizing continuous or near continuousdata recording.

Logged data can be analyzed further for detailed data analysis. Infurther embodiments, the glucose monitor system 1001 may be used in ahospital environment or the like. Still further embodiments of thepresent invention may include one or more buttons 1122, 1124, 1126 and1128 on the glucose monitor 18 to program the monitor 18, to record dataand events for later analysis, correlation, or the like. In addition,the glucose monitor may include an on/off button 1130 for compliancewith safety standards and regulations to temporarily suspendtransmissions or recording. The glucose monitor 18 may also be combinedwith other medical devices to combine other patient data through acommon data network and telemetry system. In alternative embodiments,the glucose monitor 18 may be designed as a Holter-type system thatincludes a Holter-type recorder that interfaces with a glucose monitor,processor, computer of the like, such as disclosed in U.S. patentapplication Ser. No. 09/246,661 filed Feb. 5, 1999 and entitled “AnAnalyte Sensor and Holter-Type Monitor System and Method of Using theSame”, which is herein incorporated by reference. Further embodimentsmay use wireless communication between the sensor set 1010 and theglucose monitor 18 utilizing a telemetered glucose monitor transmitteras shown and described in U.S. patent application Ser. No. 09/377,472,filed Aug. 19, 1999 and entitled “Telemetered Characteristic MonitorSystem and Method of Making the same”, which is herein incorporated byreference.

As shown in FIGS. 30 and 31, a sensor set 1010 is provided for placementof a flexible sensor 1012 (see FIG. 31), or the like, at a selected sitein the body of a user. The sensor set 1010 includes a hollow, slottedinsertion needle 1014, and a cannula 1016. The needle 1014 is used tofacilitate placement of the cannula 1016 at the insertion site. Thecannula 1016 includes a sensing portion 1018 of the sensor 1012 toexpose one or more sensor electrodes 1020 to the user's bodily fluidsthrough a window 1022 formed in the cannula 1016. After insertion, theinsertion needle 1014 is withdrawn to leave the cannula 1016 with thesensing portion 1018 and the sensor electrodes 1020 in place at theselected insertion site.

Further description of flexible thin film sensors of this general typeare be found in U.S. Pat. No. 5,391,250, entitled METHOD OF FABRICATINGTHIN FILM SENSORS, which is herein incorporated by reference. Theconnection portion 1024 may be conveniently connected electrically tothe sensor monitor (not shown), a glucose monitor 18, or a dataprocessor 200, computer, communication station, or the like, by aconnector block 1028 (or the like) as shown and described in U.S. Pat.No. 5,482,473, entitled FLEX CIRCUIT CONNECTOR, which is also hereinincorporated by reference.

The sensor 1012 is mounted in a mounting base 1030 adapted for placementonto the skin of a user. As shown, the mounting base 1030 is a generallyrectangular pad having an underside surface coated with a suitablepressure sensitive adhesive layer 1032, with a peel-off paper strip 1034normally provided to cover and protect the adhesive layer 1032, untilthe sensor set 1010 is ready for use. As shown in FIG. 32, the mountingbase 1030 includes upper and lower layers 1036 and 1038, with theconnection portion 1024 of the flexible sensor 1012 being sandwichedbetween the layers 1036 and 1038. The connection portion 1024 has aforward section joined to the sensing portion 1018 of the sensor 1012,which is folded angularly to extend downwardly through a bore 1040formed in the lower base layer 1038.

The insertion needle 1014 is adapted for slide-fit reception through aneedle port 1042 formed in the upper base layer 1036 and further throughthe lower bore 1040 in the lower base layer 1038. As shown, theinsertion needle 1014 has a sharpened tip 1044 and an open slot 1046which extends longitudinally from the tip 1044 at the underside of theneedle 1014 to a position at least within the bore 1040 in the lowerbase layer 1036. Above the mounting base 1030, the insertion needle 1014may have a full round cross-sectional shape, and may be closed off at arear end of the needle 1014. Further description of the needle 1014 andthe sensor set 1010 are found in U.S. Pat. No. 5,586,553, entitled“TRANSCUTANEOUS SENSOR INSERTION SET” and co-pending U.S. patentapplication Ser. No. 09/346,835, entitled “DISPOSABLE SENSOR INSERTIONASSEMBLY,” which are herein incorporated by reference.

The cannula 1016 is best shown in FIGS. 30 and 31, and includes a firstportion 1048 having partly-circular cross-section to fit within theinsertion needle 1014 that extends downwardly from the mounting base1030. In alternative embodiments, the first portion 1048 may be formedwith a solid core; rather than a hollow core. In preferred embodiments,the cannula 1016 is constructed from a suitable medical grade plastic orelastomer, such as polytetrafluoroethylene, silicone, or the like. Thecannula 1016 also defines an open lumen 1050 in a second portion 1052for receiving, protecting and guideably supporting the sensing portion1018 of the sensor 1012.

As shown in FIGS. 30 and 31, the glucose monitor 18 is coupled to asensor set 1010 by a cable 1102 through a connector 1104 that iselectrically coupled to the connector block 1028 of the connectorportion 1024 of the sensor set 1010. In preferred embodiments, the plugconnector 1103 of the cable 1102 is connected to the glucose monitor 18through a plug receptacle 1105. In alternative embodiments, the cable1102 may be omitted, and the glucose monitor 100 may include anappropriate connector (not shown) for direct connection to the connectorportion 1024 of the subcutaneous glucose sensor set 1010 or thesubcutaneous glucose sensor set 1010 may be modified to have theconnector portion 1024 positioned at a different location, such as forexample, the top of the subcutaneous sensor set 1010 to facilitateplacement of the glucose monitor 18 over the sensor set 1010.

The glucose monitor 18 includes a housing 1106 that supports a printedcircuit board 1108, batteries 1110, memory storage 1112, the cable 1102with the plug connector 1103, and the plug receptacle 1105. In preferredembodiments, the housing 1106 is formed from an upper case 1114 and alower case 1116 that are sealed with an ultrasonic weld to form awaterproof (or resistant) seal to permit cleaning by immersion (orswabbing) with water, cleaners, alcohol or the like. As shown, the lowercase 1116 may have an underside surface that includes a belt clip 1118(or the like) to attach to a user's clothing.

As shown in FIG. 31, the PC 14, data processor 200, computer,communication station 10, or the like, may include a display 214 that isused to display the results of the measurement received from the sensor1018 in the glucose sensor set 1010 received via a download from theglucose monitor 18. The results and information displayed includes, butis not limited to, trending information of the characteristic (e.g.,rate of change of glucose), graphs of historical data, averagecharacteristic levels (e.g., glucose), or the like. Alternativeembodiments include the ability to scroll through the data. The display214 may also be used with buttons (not shown) on the PC 14, dataprocessor 200, laptop, communication station 10, or the like, to programor update data in the data processor 200 or PC 14. In preferredembodiments, the glucose monitor 18 includes a display 1132 to assistthe user in programming the glucose monitor 18, entering data,stabilizing, calibrating, downloading data, or the like.

After a sensor set 1010 has been used for a period of time, it isreplaced. The user will disconnect the glucose sensor set 1010 from thecable 1102 and glucose monitor 18. In preferred embodiments, if anadditional test is required and/or desired, the glucose monitor 18 isconnected to a new sensor set 1010. A new sensor set 1010 and sensor1012 are attached to the glucose monitor 18 and connected to the user'sbody. Recording then continues, as with the previous sensor 1012.Finally, the data stored in the memory 1112 of the glucose monitor 18 isdownloaded (or transmitted) to the PC 14, data processor 200, laptop,communication station 10, or the like, for analysis and review.

FIG. 32 shows a simplified block diagram of the communication station 10shown in FIGS. 1-3 and described above. However, FIG. 33 shows asimplified circuit schematic of another embodiment of a communicationstation 500 that can be used with the medical devices described above.The communication station 500 shown FIG. 33 includes severalimprovements that increase the utility and capabilities of thecommunication station 500 to store and transmit data for later analysisby the software in the PC 14. The communication station 500, like thecommunication station 10 above, will communicate with infusion pumps 12,glucose monitors 18, and blood glucose meters 24 that have thecapability of communicating over an RS-232 serial port 26. In additionto interfaces for the devices mentioned above, the communication station500, like the communication station 10 above, will also incorporate aRS-232 serial port 16 for communication with a PC 14 or other localdevice. However, the communication station 500 will also include a modem502 and a telephone interface for communication with a network-basedinformation management service, such as is described in U.S. PatentApplication Ser. No. 60/143,981 filed May 20, 1999 and entitled“Diabetes Integrated Management System”, which is herein incorporated byreference. Reports similar to those described above may be generated bythe network based information management service. Alternativeembodiments may utilize other telecommunication architectures to connectwith the network based information management service, such as DSL,Ethernet, LAN networks, TCIP, Tolken ring, Novel, IR, RF, and otherwireless links, or the like.

The communication station PC software will have the capabilities listedbelow: an ability to store and process complete data sets from severaldevices in preparation for uploading the data to an application programor network service; an ability to display simple text instructions on anLCD display 504; an ability to enter data such as meter type, phonenumber, or the like, with the amount of data entry required to beminimized; an ability to update code in the field; an ability to storeunique device serial number. In addition, the communication station 500will have hardware support for RF communications with the infusion pump12, glucose monitors 18, glucose meters 24, or the like, that support RFcommunications for program instructions and/or data transmission.Additional features may be incorporated into future releases of thesoftware for the communication station following the productmanufacturer date, and thus the communication stations in the field willhave the capability to be updated to newer releases of software usingthe in-field code update capability of the software.

As shown in FIG. 33, the communication station will include thefollowing hardware components: a DragonBall 68EZ328 CPU 506 running at16 MHz; 2 MByte flash memory 508 that is writeable at least 50,000 timesand 8 MByte DRAM 510 or 4 MB of RAM; an interface 512 to a SeikoG241D01R000 graphics LCD 504; four momentary switches for interface toan elastomeric keypad 514; a Real Time Clock 516, that is batterybacked-up for 5 years; two RJ11 phone line connectors 518 and 520 with apassthrough relay; a modem 502; one female and one male DB9 RS232 ports16 and 26, with the capability of multiplexing RX and TX to providepassthrough between the ports; a serial connection with signalmultiplexing that allows redirection of the serial port to either the IRCircuit or the RF Circuit; an unregulated 9VDC, 1 Amp power input 32,with out the need of a power switch; a piezo beeper 522 capable ofgenerating multiple tones.

As discussed, the communication station 500 includes a processor boardthat has two RJ11 phone line connectors 518 and 520. A passthrough relay524 will allow the second RJ11 connector 520 to be disconnected from thefirst during modem communications. A status bit will be provided toindicate whether the line is in use. The processor board of thecommunication station 500 will also be compatible with the Conexantsocket modem technology and will be useable with 14.4 Kbps, 33.6 Kbps,and 33.6 Kbps world class modems. In alternative embodiments, the RJ11connectors 518 and 520 may be formed separate from the processor board,or replaced by a different connector format. In further alternativeembodiments, the communication station may use higher or lower modemspeeds and modems compatible with other communication standards, such asDSL, TCIP, ISDN, or the like. The processor board of the communicationstation will provide two RS232 ports 16 and 26 with one male and onefemale DB9 connectors. Signal multiplexing will provide a passthroughwhich connects the two serial ports to each other. The RS-232Transceiver shall be ±15 kV ESD-Protected. EMI filtering of the RX andTX signals shall be provided. Only RX, TX, and GND signals need to beprovided to the processor, however all standard RS232 signals shall berouted when the two ports 16 and 26 are connected in passthrough mode.In alternative embodiments, different connector specifications orformats may be used.

The processor board will have IR circuitry 526 for communication withthe infusion pumps 12, and glucose monitors 18 having IR data transfercircuitry compatible with the circuitry of the communication station.The processor board will also have RF circuitry 528 for communicationwith the infusion pumps, glucose monitors and future devices that haveRF data transfer or programming capabilities. The communication station500 is also designed to communicate with several glucose meters such asthe Medisense Precision QID, and will support for example the followingPrecision QID commands: Read Sensor and Erase Sensor. The One Touchglucose meter will be supported for the following commands: DM?—Send theMeter's software version and date; DM@—Send the Meter's serial number;DMF—Send date and time from the Meter's clock; DMI—dump the data logfrom the Meter's memory; and DMP—dump blood, control, and check striprecords from the Meter's memory. In alternative embodiments, othermeters and other commands may be supported.

The processor board shall be have a beeper 522 which can generate toneswhen driven by the Pulse Width Modulation capability of the DragonballEZ processor 506. In alternative embodiments, other audio producingmechanisms, such as a speaker, sound card, or the like, may be used. Theprocessor board is responsible for regulating the 9VDC, 1 Ampunregulated power that is provided. The power connector 32 will be aKycon Part number KLD-0202-B. The input circuitry will provide TransientSurge protection, EMI filtering, and a Resettable Fuse.

The communication station 500 includes a improved user interface 512 tomake the communication station 500 more versatile. The communicationstation 500 uses a Seiko Instruments G241D01R000 graphics LCD 504 thathas 240×160 pixels. Assuming a minimal 8×6 pixel font, this display iscapable of displaying up to 30×26 characters if oriented vertically or20×40 characters if oriented horizontally. Preferably, the LCD 504 has aLED backlight. In alternative embodiments, other display devices, suchas CRT, plasma, or the like may be used, different LCD types and sizesmay be used, and the LCD may omit a backlight.

The user interacts with the communication station 500 through the use oftwo soft keys 552 and 554 and two arrow keys 556 and 558 used with thedisplay on the LCD 504. Feedback is received via the LCD and beeper. Theuser interface allows the user to navigate a variety of screensincluding: Menu Screens; Numeric Entry Screens; Softkey Screens; andCheck Screens. An example of a typical LCD window is shown in FIG. 34.

FIG. 35 illustrates the main screen, which allows the user to move aninverted bar over each selection in a list using the arrow keys 556 and558. When the desired item is highlighted the user presses the softkey554 corresponding to the select option and that item is selected. Afterselection, the selected option or software function is executed.

FIG. 36 illustrates the alpha-numeric entry window, which allows theuser to scroll through a list of alphanumeric options using the arrowkeys 556 and 558. Once the desired entry is found the user accepts thatentry by pressing the softkey 554 corresponding to the Next operation.The other softkey 552 can be used to either allow the user to back up acharacter or cancel entirely out of the screen. Once the user enters thelast number, the screen is complete.

FIG. 37 illustrates the softkey screen, which allows the user to decideon simple options where the user only has two choices that can bepresented on a softkey screen. A softkey screen simply presents eachoption as an individual softkey or as a Yes 552 or No 554.

FIG. 38 illustrates the check screen which, like the menu screen, usesthe arrow keys 556 and 558 to move an inverted bar up and down over alist of options. Unlike the menu screen, selecting the option simplyplaces a check mark by the highlighted item. When the user is done withthe screen they may press the softkey 554 labeled done.

Software in the communication station 500 will support the userscenarios listed below.

Scenario 1: Initial Setup

This scenario describes the first user interaction with thecommunication station 500. For instance, the communication station 500is powered on by plugging in the device. An initial greeting ispresented to the user such as “Welcome to the MiniMed Com Station. I'mgoing to ask you a few questions to set things up.” A softkey labelcontinue is presented. The user presses continue and is presented withthe screen “Do you need to do anything special to get an outside line,such as dial 9?” The user is presented with softkeys labeled yes and no.If the user hits yes, they are presented with a numeric entry screenwhich allows them to enter the number required for and outside line. Thenext question the user is presented with is “Do you have call waiting?”.The user is presented with softkeys labeled yes and no. If the user hitsyes, they are presented with a numeric entry screen which allows them toenter the number required to disable call waiting. The user is presentedwith a screen saying “Congratulations! Setup is complete. If you everwant to change your setup you can do so from the main menu” A softkeylabel continue is presented. The user is then presented with the mainscreen. The main screen is a menu screen with three options: Setup,Collection information, Send information to a remote source (see FIG.35).

Scenario 2: Typical Data Collection and Upload

This scenario describes the typical user interaction with thecommunication station 500. For instance, the user places his infusionpump 12 or glucose monitor 18 in the cradle 20 or connects a glucosemeter 24 to the serial port 26. The user selects collect informationfrom the LCD screen 504. The user is presented with a list of devices.The user selects the infusion pump 12, glucose monitor 18, and/orglucose meter 24 that is to be download from. The user receives amessage such as “Communicating with <name of device>. Please wait . . .” Once communication is complete a message such as “Communicationcomplete. Do you want to send the collected information to a remotelocation?” If the user chooses to send the data to the remote location,they are presented with a screen that says “Contacting Remote NetworkServices, please wait.”During the data transfer, the LCD 504 willdisplay a screen that says “Data being sent to Remote Network Services,please wait . . . ” A progress bar indicates the time remaining. Oncethe data has been sent, a message such as “Finished sending data toRemote Network Services.” The user presses continue and is returned tothe main menu.

Scenario 3: Typical PC Use

This scenario describes the typical user interaction with the device.For instance, following the directions on the PC screen, the userconnects a serial cable from their PC 14 to the communication station500. When the user clicks a button on the PC screen, the communicationstation 500 screen displays the message “The communication station is inPC controlled mode.” The user follows the instructions on the PC screen.Once the session is terminated, the communication station 500 returns tothe main menu.

As discussed above, the communication station 500 can communicate with anetwork-based data management service that will gather device andpatient data in a central location and produce reports for use by careproviders, managed care organizations, and patients, such as disclosedin U.S. Patent Application Ser. No. 60/143,981 filed May 20, 1999 andentitled “Diabetes Integrated Management System”, which is incorporatedby reference herein. The initial goal of a data management service willbe to gather device data with minimal user interaction and fax a reportto the care provider's office in advance of a patient appointment. Thisservice will rely on communications devices and software in either thepatient's homes or the care provider's offices to gather device data andtransmit it to the data management service via modem. A communicationstation 500 will be used as a communication device to gather data fromcurrent medical devices and to interact with the network-based datamanagement service. Future phases of the data management service willsupport direct patient interaction with the service for the purpose ofconducting medical and marketing surveys, presenting medicalinstructions, conducting tutorials, and electronic ordering of supplies.

The following describes a typical interaction between the communicationstation 500 and the network service: For instance, the communicationstation 500 calls network server and establishes initial connection. Theserver responds with a successful login in message and server time. Thecommunication station 500 records this time. In preferred embodiments,the network server never calls the communication station 500; however,in alternative embodiments, the network server may call thecommunication station 500 at periodic intervals or to check on thestatus of a patient that is overdue to transmit data. Next, thecommunication station 500 downloads an instr.bat file. This file tellsthe communication station that it needs to update its code usingnewcode.bin and update its screens using newscreens.xml. Thecommunication station 500 looks and sees if there are any specialinstructions just for it on the network server. To do this it looks foran instruction file with it's serial number (i.e. SN1234_instr.bat).This file might tell it that it has a couple of messages waitingspecifically for it (i.e. SN1234_msg1.xml and SN1234_msg2.xml). Thecommunication station 500 then sends a SN1234_hist.dat file. This filecontains a log of errors encountered and other communication station 500status information. Next, the communication station 500 sends all thedownload data files in its memory using the instr.bat file or theSN1234_instr.bat if such a file exists. After the transfer is complete,a success message is sent, and either the network server or thecommunication station 500 will terminate the connection.

The data downloaded from the devices shall be stored in the exact formatthey are received. Data shall be transferred using Xmodem-1K. Onmanufacture the Real Time Clock 516 is set in such a way that it iseffectively a counter counting minutes and seconds since the date ofmanufacture. This counter is battery backed and never reset. It providesan absolute reference against which all other times are measured. Whendevices are downloaded, the time of the device is recorded along withthe manufacture counter time. This will enable the conversion of thedata from device time to manufacture counter time. In this way, nomatter what the variety of device times, all data can be normalized tomanufacture counter time. When the communication station 500 connectswith the network, the network responds with its time. Upon reception ofthe network time, the network time is recorded along with thecorresponding manufacture counter time. This will enable the conversionof the manufacture counter normalized timestamps to network time.

The communication station 500 will have the ability to communicate witha PC 14 via an RS232 link to a DB9 com port 16. There is a PC ControlledMode, where upon reception of a command to put the communication station500 in PC Controlled Mode, the communication station 500 locks out allnormal functions and places the message “The communication station isunder the control of your PC, press Cancel to end control”. Thecommunication station remains in PC Controlled Mode until released bythe PC 14, the cancel softkey is pressed on the communication station500, or the communication station 500 times out. In PC Controlled Modethe following commands are available: program the communication station500; program the PIC Microcontroller in the RF section of thecommunication station 500; put a message on the LCD display 504 of thecommunication station 500; put the communication station 500 serialports 26 and 520 in pass through mode; directly communicate seriallywith the IR transmitters and receivers 22; directly communicate seriallywith the RF transceiver 526; determine what files are stored in thecommunication station memory 508 and 510 and download them; instruct thecommunication station 500 to download data from specific devices (suchas an infusion pump 12) to the file system. This differs from direct IRor RF communications in that the PC 14 relies on the communicationstation to handle the protocol for communicating with these devices; anddownload the communication station 500 history and status information.There is also a communication station 500 Debug Mode, which is similarto PC Controlled mode in that it involves serial communication with aPC. However, unlike PC controlled mode, the Debug Mode does not lock outnormal communication station 500 functioning. In Debug Mode thefollowing commands are available: program the communication station 500;program the PIC Microcontroller in the RF section of the communicationstation 500; determine what files are stored in the communicationstation memory 508 and 510 and download them; download the communicationstation 500 history and status information; simulate a keypress; adjustthe LCD contrast 504; batch program the communication station 500 andthe PIC microcontroller (this allows multiple devices to be programmedsimultaneously); and failure simulation.

As discussed above, the communication station 500 will have the abilityto perform several levels of in field code update, including: PICMicrocontroller update; screens update; normal code update; and BootBlock update. The PIC Microcontroller update is responsible for updatingcertain aspects of the RF protocol used in communicating with the RFdata transmitting and programmable devices. The Screens update changesthe screen wording to access new functions and features. The Normal CodeUpdate updates everything except for a small amount of boot code. If anormal code update fails, the boot block provides the code for recoveryand retry. The Boot Block Update remotely updates the boot block.However, if the update of this portion of code fails, the device willhave to be returned for reprogramming.

While the description above refers to particular embodiments of thepresent invention, it will be understood that many modifications may bemade without departing from the spirit thereof. The accompanying claimsare intended to cover such modifications as would fall within the truescope and spirit of the present invention.

The presently disclosed embodiments are therefore to be considered inall respects as illustrative and not restrictive, the scope of theinvention being indicated by the appended claims, rather than theforegoing description, and all changes which come within the meaning andrange of equivalency of the claims are therefore intended to be embracedtherein.

What is claimed is:
 1. A communication system for monitoring a medical condition for a patient, comprising: a plurality of medical devices including a continuous glucose monitor for obtaining continuous glucose level measurement data for the patient over a plurality of days and a glucose meter for obtaining discrete glucose level calibration and reference data over the plurality of days that is used by the continuous glucose monitor to calibrate the continuous glucose level measurement data for the patient over the plurality of days; a processing device including: a processing device display, and at least one embedded computer program; and a communication device for providing a communication link between the plurality of medical devices and the processing device such that data may be transferred from the plurality of medical devices to the processing device, wherein the at least one embedded computer program causes the processing device to perform: generating a patient data file, downloading the continuous glucose level measurement data for the patient obtained by the continuous glucose monitor over the plurality of days and the discrete glucose level calibration and reference data obtained by the glucose meter over the plurality of days, recording the downloaded data in the patient data file, integrating the downloaded data from the continuous glucose monitor and the glucose meter to present contemporaneous information showing the relationship between the continuous glucose monitor and the glucose meter, presenting the integrated data in a modal day report format including a modal day graph having a single 24-hour day time scale on a first axis and a glucose level scale on a second axis, and displaying on the processing device display the continuous glucose level measurement data obtained over a first day of the plurality of days and the discrete glucose level calibration and reference data obtained over the first day of the plurality of days that is used to calibrate the continuous glucose level measurement data during the first day in an overlaid fashion relative to the continuous glucose level measurement data obtained over a second day of the plurality of days and the discrete glucose level calibration and reference data obtained over the second day of the plurality of days that is used to calibrate the continuous glucose level measurement data during the second day on the same, single 24-hour day time scale within the modal day graph.
 2. The communication system of claim 1, wherein the continuous glucose level measurement data obtained over the first day is displayed in the modal day graph in a first color, and the continuous glucose level measurement data obtained over the second day is displayed in the modal day graph in a second color different from the first color.
 3. The communication system of claim 2, wherein the discrete glucose level calibration and reference data obtained during the first day is displayed in the modal day graph in the first color, and the discrete glucose level calibration and reference data obtained over the second day is displayed in the modal day graph in the second color.
 4. The communication system of claim 1, wherein the continuous glucose level measurement data obtained over the first day is displayed as a first continuous line graphical representation of blood glucose levels on the modal day graph, and the continuous glucose level measurement data obtained over the second day is displayed as a second continuous line graphical representation of blood glucose levels on the modal day graph.
 5. The communication system of claim 1, wherein the discrete glucose level calibration and reference data obtained over the first day and the discrete glucose level calibration and reference data obtained over the second day is displayed as one or more discrete point graphical representations on the modal day graph, each discrete point graphical representation corresponding to a discrete blood glucose level measurement included in the discrete glucose level calibration and reference data obtained during the first and second days that is used to calibrate the continuous glucose level measurement data obtained over the first and second days.
 6. The communication system of claim 1, wherein the discrete glucose level calibration and reference obtained during the first and second days include at least one of discrete time stamped glucose level measurements, current clock settings, and event markers.
 7. The communication system of claim 1, wherein the continuous glucose level measurement data obtained during the first and second days include at least one of sensor glucose level measurements, current clock settings, event markers, and manually entered glucose level calibration and reference measurements.
 8. The communication system of claim 1, wherein the modal day report format further includes a tabular chart, and the at least one embedded computer program further causes the processing device to perform: calculating an average glucose level based on the continuous glucose level measurement data obtained by the continuous glucose monitor over the plurality of days, displaying on the processing device display the average glucose level as a straight line along the second axis within the modal day graph, and displaying on the processing device display the average glucose level in the tabular chart.
 9. The communication system of claim 1, wherein the modal day report format further includes a tabular chart, and the at least one embedded computer program further causes the processing device to perform: calculating a standard deviation based on the continuous glucose level measurement data obtained by the continuous glucose monitor over the plurality of days, and displaying on the processing device display the calculated standard deviation in the tabular chart.
 10. The communication system of claim 1, wherein the modal day report format further includes a tabular or pie chart, and the at least one embedded computer program further causes the processing device to perform: calculating a percentage of the continuous glucose level measurement data obtained by the continuous glucose monitor over the plurality of days that is equal to or above a hyperglycemic limit for the patient, calculating a percentage of the continuous glucose level measurement data obtained by the continuous glucose monitor over the plurality of days that is equal to or below a hypoglycemic limit for the patient, calculating a percentage of the continuous glucose level measurement data obtained by the continuous glucose monitor over the plurality of days that is below the hyperglycemic limit and above the hypoglycemic limit for the patient, and displaying on the processing device display the calculated percentages in the tabular or pie chart.
 11. The communication system of claim 1, wherein the modal day report format further includes a tabular chart, and the at least one embedded computer program further causes the processing device to perform: determining a maximum glucose level measurement and a minimum glucose level measurement included in the continuous glucose level measurement data obtained by the continuous glucose monitor over the plurality of days, and displaying on the processing device display the maximum and minimum glucose level measurements in the tabular chart. 